Endovascular graft

ABSTRACT

An endovascular graft, which is configured to conform to the morphology of a vessel to be treated, includes a tubular ePTFE structure; an inflatable ePTFE structure disposed over at least a portion of the ePTFE tubular structure; and an injection port in fluid communication with the inflatable ePTFE structure for inflation of the inflatable ePTFE structure with an inflation medium. The inflatable ePTFE structure may be longitudinally disposed over the tubular ePTFE structure. The ePTFE structure may be a bifurcated structure having first and second bifurcated tubular structures, where the inflatable ePTFE structure is disposed over at least a portion of the first and second bifurcated tubular structures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.10/132,754, filed Apr. 24, 2002, which is a continuation of U.S.application Ser. No. 09/133,978, filed Aug. 14, 1998, now U.S. Pat. No.6,395,019, which claim the benefit of U.S. Provisional Application No.60/074,112, filed Feb. 9, 1998, the contents of all of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to a system and method for the treatmentof disorders of the vasculature. More specifically, a system and methodfor treatment of abdominal aortic aneurysm and the like, which is acondition manifested by expansion and weakening of the aorta below thediaphragm. Such conditions require intervention due to the severity ofthe sequelae, which frequently is death. Prior methods of treatingaortic aneurysm have consisted of invasive surgical methods with graftplacement within the aorta as a reinforcing member of the artery.However, such a procedure requires a surgical cut down to access thevessel, which in turn can result in a catastrophic rupture of theaneurysm due to the decreased external pressure from the organs andtissues surrounding the aorta, which are moved during the procedure togain access to the vessel. Accordingly, surgical procedures have a highmortality rate due to the possibility of the rupture discussed above inaddition to other factors. Other factors can include poor physicalcondition of the patient due to blood loss, anuria, and low bloodpressure associated with the aortic abdominal aneurysm. An example of asurgical procedure is described in a book entitled Surgical Treatment ofAortic Aneurysms by Denton A. Cooley, M. D., published in 1986 by W.B.Saunders Company.

Due to the inherent risks and complexities of surgical procedures,various attempts have been made in the development of alternativemethods for deployment of grafts within aortic aneurysms. One suchmethod is the non-invasive technique of percutaneous delivery by acatheter-based system. Such a method is described in Lawrence, Jr. e tal. in “Percutaneous endovascular graft: experimental evaluation”,Radiology (May 1987). Lawrence described therein the use of a Gianturcostent as disclosed in U.S. Pat. No. 4,580,568. The stent is used toposition a Dacron fabric graft within the vessel. The Dacron graft iscompressed within the catheter and then deployed within the vessel to betreated. A similar procedure has also been described by Mirich et al. in“Percutaneously placed endovascular grafts for aortic aneurysms:feasibility study,” Radiology (March 1989). Mirich describes therein aself-expanding metallic structure covered by a nylon fabric, with saidstructure being anchored by barbs at the proximal and distal ends.

One of the primary deficiencies of the existing percutaneous devices andmethods has been that the grafts and the delivery catheters used todeliver the grafts are relatively large in profile, often up to 24French and greater, and stiff in bending. The large profile and bendingstiffness makes delivery through the irregular and tortuous arteries ofdiseased vessels difficult and risky. In particular, the iliac arteriesare often too narrow or irregular for the passage of a percutaneousdevice. Because of this, non-invasive percutaneous graft delivery fortreatment of aortic aneurysm is not available to many patients who wouldbenefit from it.

Another contraindication for current percutaneous grafting methods anddevices is a vessel treatment site with high neck angulation whichprecludes a proper fit between the graft and the vessel wall. Animproper fit or seal between the graft and the vessel wall can result inleaks or areas of high stress imposed upon the diseased vessel whichlead to reduced graft efficacy and possibly rupture of the aneurysm.

While the above methods have shown some promise with regard to treatingabdominal aortic aneurysms with non-invasive methods, there remains aneed for an endovascular graft system which can be deployedpercutaneously in a small diameter flexible catheter system. Inaddition, there is a need for a graft which conforms more closely to thecontours of an aortic aneurysm which are often quite irregular andangulated and vary from patient to patient. The present inventionsatisfies these and other needs.

SUMMARY OF THE INVENTION

The present invention is directed generally to an endovascular graft forvascular treatment and a method for manufacturing and using the graft.The graft generally has an inflatable tubular frame structure which canbe configured to conform to the morphology of a patient's vessel to betreated. The frame structure has a proximal end and a distal end with aninflatable cuff disposed on at least one end and preferably both. Theinflatable cuffs can be reduced in diameter and profile when deflatedfor introduction into a patient's vasculature by a catheter baseddelivery system or other suitable means. The inflatable cuffs provide asufficiently rigid structure when inflated which supports the graft andseals the graft against the interior surface of the vessel in which itis being deployed. One or more elongated inflatable channels may also bedisposed on the graft. Preferably, the elongated channel is disposedbetween and in fluid communication with a proximal and distal inflatablecuff. The channel provides the desired stiffness upon inflation,prevents kinking of the graft frame, and facilitates deployment of thegraft within a patient's body passageway. The elongated inflatablechannel can be in a longitudinal or linear configuration with respect tothe graft, but is preferably shaped as a helix disposed about the graft.Other orientations such as interconnecting grids or rings may also besuitable for the elongated channels. The inflatable cuffs and theelongated channel contain fluid tight chambers which are generally influid communication with each other but which may also be separated byvalves or rupture discs therein to selectively control the sequence ofinflation or deployment. The fluid tight chambers are typically accessedby an injection port which is configured to accept a pressurized sourceof gas, fluid, particles, gel or combination thereof and which is influid particle, gel or combination thereof and which is a fluidcommunication with at least one of the fluid tight chambers. A fluidwhich sets, hardens or gels over time can also be used. The number ofelongated channels can vary with the specific configuration of the graftas adapted to a given indication, but generally, the number of channelsranges from 1 to 25, preferably 2 to about 8.

A proximal neck portion may be secured to the proximal inflatable cuff.The proximal neck portion has a flexible tubular structure that has adiameter similar to the proximal inflatable cuff. The proximal neckportion can be configured as a straight tubular section or can betapered distally or proximally to an increased or decreased diameter.Preferably, the proximal neck portion is secured and sealed to theproximal inflatable cuff and tapers proximally to an increased diameterso as to engage the inside surface of a vessel wall which provides asealing function in addition to that of the proximal inflatable cuff.Such a configuration also smoothes the transition for fluid flow fromthe vessel of a patient to the lumen or channel within the endovasculargraft. The proximal neck portion has an inlet axis that preferably hasan angular bias with respect to a longitudinal axis of the graft.

Preferably, the graft has a monolithic structure wherein the materialthat comprises the inflatable cuffs and channels extends between theseelements in a thin flexible layer that defines a longitudinal lumen toconfine a flow of blood or other fluid therethrough. Such a monolithicstructure can be made from a variety of suitable polymers including PVC,polyurethane, polyethylene and fluoropolymers such as TFE, PTFE andePTFE. Additional stiffness or reinforcement can be added to the graftby the addition of metal or plastic inserts or battens to the graft,which can also facilitate positioning and deployment of the graft priorto inflation of an inflatable portion of the graft.

In another embodiment, the graft has a thin flexible layer disposed overor between a proximal inflatable cuff, a distal inflatable cuff, and anelongated inflatable channel of the frame. The thin flexible layer ismade of a material differing from the material of the cuffs or elongatedchannel. The barrier is shaped so as to form a tubular structuredefining a longitudinal lumen or channel to confine a flow of bloodtherethrough. The flexible barrier may be made of a variety of suitablematerials such as DACRON®, NYLON®, or fluoropolymers such as TEFLON® orthe like.

An endovascular graft having features of the invention may be made in atubular configuration of a flexible layer material such as Dacron, Nylonor fluoropolymers as discussed above. The inflatable cuffs and elongatedchannels are formed separately and bonded thereto. The inflatable cuffsand channels may also be made from the same layer material, i.e.,Dacron, Teflon, or Nylon with a fluid impermeable membrane or bladderdisposed within the cuff or channel so as to make it fluid tight. Tolimit permeability, the material in the regions of the cuffs andchannels may also be treated with a coating or otherwise be processed bymethods such as thermo-mechanical compaction.

In one embodiment of the invention, an expansion member is attached tothe proximal end of the frame structure of the graft or to a proximalneck portion of the graft. Expansion members may also be attached to thedistal end of the graft. Preferably, the expansion member is made of anexpandable ring or linked expandable rings of pseudoelastic shape memoryalloy which is self expanding and helps to mechanically anchor theproximal end of the graft to a body channel to prevent axialdisplacement of the graft once it is deployed. By having an expansionmember which is distinct from the proximal cuff, the sealing function ofthe cuff, which requires supple conformation to the vessel wall withoutexcessive radial force, can be separated from the anchoring function ofthe expansion member, which can require significant radial force. Thisallows each function to be optimized without compromising the functionof the other. It also allows the anchoring function which can requiremore radial force on the vessel wall to be located more proximal fromthe aneurysm than the cuff, and therefor be positioned in a healthierportion of the vessel which is better able to withstand the radial forcerequired for the anchoring function. In addition, the cuff and expansionmembers can be separated spatially in a longitudinal direction with thegraft in a collapsed state for delivery which allows for a lower moreflexible profile for percutaneous delivery. Such a configuration makes acollapsed delivery profile of 12-16 French possible, preferably below 12French.

The expandable ring or rings of the expansion member may be formed in acontinuous loop having a serpentine or zig-zag pattern along acircumference of the loop. Any other similar configuration could be usedthat would allow radial expansion of the ring. The expansion member maybe made of suitable high strength metals such as stainless steel,Nitinol or other shape memory alloys, or other suitable high strengthcomposites or polymers. The expansion member may be made from highmemory materials such as Nitinol or low memory materials such asstainless steel depending on the configuration of the endovasculargraft, the morphology of the deployment site, and the mode of deliveryand deployment of the graft.

The expansion member preferably has an inlet axis which forms an inletaxis angle in relation to a longitudinal axis of the graft. The angledinlet axis allows the graft to better conform to the morphology of apatient's vasculature in patients who have an angulated neck aneurysmmorphology. The inlet axis angle can be from about 0 to about 90degrees, preferably about 20 degrees to about 30 degrees. Some or all ofthe inlet axis angle can be achieved in a proximal neck portion of thegraft, to which the expansion member may be attached. An expansionmember or members may also be attached to the distal end of the graft.

In another embodiment of the invention, the graft may be bifurcated atthe distal end of a main body portion of the graft and have at least twobifurcated portions with longitudinal lumens in fluid communication witha longitudinal lumen of the main body portion. The first bifurcatedportion and second bifurcated portion can be formed from a structuresimilar to that of a main body portion with optional inflatable cuffs ateither the proximal or distal end. One or more elongated channels can bedisposed between the inflatable cuffs.

The size and angular orientation of the bifurcated portions can vary,however, they are generally configured to have an outer diameter that iscompatible with the inner diameter of a patient's iliac arteries. Thebifurcated portions can also be adapted to use in a patient's renalarteries or other suitable indication. The distal ends of the bifurcatedportions may also have expansion members attached thereto in order toanchor or expand, or both anchor and expand said distal ends within thebody passageway being treated. The expansion members for the distal endsof the bifurcated portions can have similar structure to the expansionmember attached to the proximal end or proximal neck portion of the mainbody portion. The expansion members are preferably made from a shapememory material such as Nitinol.

In bifurcated embodiments of grafts having features of the inventionwhich also have a biased proximal end which forms an inlet axis angle,the direction of the bias or angulation can be important with regard toachieving a proper fit between the graft and the morphology of thedeployment site. Generally, the angular bias of the proximal end of thegraft, proximal neck portion or proximal expansion member can be in anydirection. Preferably, the angular bias is in a direction normal to aplane defined by a longitudinal axis of the main body portion, the firstbifurcated portion and the second bifurcated portion.

In another embodiment of the invention, rupture discs or other temporaryclosures are placed between fluid tight chambers of the inflatable cuffsand elongated channel or channels of the graft and form a seal betweenthe chambers. The rupture discs may be burst or broken if sufficientforce or pressure is exerted on one side of a disc or temporary closure.Once the graft is located at the site to be treated within a bodypassageway of a patient, a pressurized gas, fluid or gel may be injectedby an inflation catheter into one of the fluid tight chambers of thegraft through an injection port. Injection of a pressurized substanceinto an inflatable cuff will cause the cuff to take a generally annularshape, although the cuff can conform to the shape of the vessel withinwhich it is deployed, and exert a sufficient radial force outwardagainst the inner surface of the body passageway to be treated in orderto provide the desired sealing function.

Multiple rupture discs can be disposed in various locations of the graftand also be configured to rupture at different pressures or burstthresholds to facilitate deployment of the graft within a bodypassageway. In a particular bifurcated embodiment of the invention, theproximal inflatable cuff of the main body portion may be positionedproximal of a junction between the branch of the abdominal aorta and theiliac arteries of a patient. As the proximal cuff is deployed byinjection of an appropriate substance into an injection port in fluidcommunication with the fluid tight chamber thereof, it will expandradially and become axially and sealingly fixed proximal to thebifurcation of the aorta. A rupture disc is located between the fluidtight chamber of the proximal cuff and the elongated inflatable channelsso that the proximal cuff may be substantially deployed before therupture disc bursts and the elongated channels begin to fill with theinjected substance. The elongated channels then fill and becomesufficiently rigid and expand to create a longitudinal lumen therein. Aspressure is increased within the fluid tight chamber, a rupture discbetween the fluid tight chamber of the elongated channels and a fluidtight chamber of the optional distal inflatable cuff or distal manifoldof the main body portion will burst and the distal inflatable cuff ormanifold will deploy and become pressurized. One of the bifurcatedportions of the graft may then be deployed as a rupture disc sealing itsfluid tight chamber from the distal inflatable cuff or manifold of themain body portion of the graft bursts as the inflation pressure isincreased. Finally, the second bifurcated portion of the graft deploysafter a rupture disc sealing its fluid tight chamber from the main bodyportion bursts.

An inflation catheter which is attached to and in fluid communicationwith the fluid tight chambers of the graft via an injection portdisposed thereon can be decoupled from the injection port aftercompletion of inflation by elevating pressure above a predeterminedlevel. The elevated pressure causes a break in a connection with theinjection port by triggering a disconnect mechanism. Alternatively, theinflation catheter can be unscrewed from its connection. The injectionport can include a check valve, seal or plug to close off the egress ofinflation material once the inflation catheter has been decoupled. Theinjection port could also be glued or twisted to seal it off.

A graft having features of the invention may also be deployed bypercutaneous delivery with a catheter based system which has aninflatable balloon member disposed within expansion members of the graftin a collapsed state. The graft is percutaneously delivered to a desiredsite. Once the graft is axially positioned, the inflatable member of theballoon may be expanded and the expansion members forced radiallyagainst the interior surface of a body channel within which it isdisposed. The expansion members may also be self expanding from aconstrained configuration once the constraint is removed. After thegraft has been positioned by the catheter system, the inflatable cuff orcuffs and elongated channel or channels of the graft are pressurized.

These and other advantages of the invention will become more apparentfrom the following detailed description of the invention when taken inconjunction with the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of an endovascular graft having featuresof the invention.

FIG. 2 shows a longitudinal cross sectional view of an endovasculargraft having a monolithic structure.

FIG. 3 shows an enlarged view of the longitudinal cross sectional viewof the endovascular graft of FIG. 2.

FIG. 4 shows a longitudinal cross-sectional view of an endovasculargraft having features of the invention.

FIG. 5 shows an enlarged view of a portion of the endovascular graftshown in FIG. 4.

FIG. 6 is a perspective view of a bifurcated endovascular graft havingfeatures of the present invention.

FIG. 7 is a transverse cross-sectional view of a bifurcated portion ofan endovascular graft taken at 7-7 of FIG. 6.

FIGS. 8A 8C depict perspective views of a bifurcated endovascular grafthaving features of the present invention in various stages ofdeployment.

FIG. 9A is an enlarged longitudinal cross sectional view of the valvethat could be used to maintain inflation of a fluid tight chamber in theendovascular graft token at 9-9 of FIG. 8A.

FIG. 9B is an enlarged longitudinal cross sectional view of analternative seal that could be used to maintain inflation of a fluidtight chamber in the endovascular graft taken at 9-9 of FIG. 8A.

FIG. 9C is an enlarged longitudinal cross sectional view of analternative sealing plug that could be used to maintain inflation offluid tight chamber in the endovascular graft taken at 9-9 of FIG. 8A.

FIG. 10 is an enlarged longitudinal cross sectional view of a rupturedisc that could be used to control the inflation sequence of aninflatable endovascular graft taken at 10-10 of FIG. 8C.

FIG. 11 is a plot of inflation pressure of an inflatable endovasculargraft with respect to time for an endovascular graft having features ofthe present invention including rupture discs which are configured toyield at various predetermined pressures.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a perspective view of an endovascular graft 10 havingfeatures of the present invention and having a proximal end 11 and adistal end 12. The graft is supported by an inflatable frame 13 whichhas a proximal end 14 and a distal end 15 and is shown in its deployedstate. The inflatable frame structure 13 has a proximal inflatable cuff16 at the proximal end 14 and an optional distal inflatable cuff 17 atthe distal end 15. The inflatable cuffs 16 and 17 can be annular inshape when deployed, although the cuffs can confirm to the shape of thevessel within which they are deployed, and can have an outside diameteror cross sectional dimension of about 10 to about 45 mm, preferablyabout 16 to about 28 mm. There is at least one elongated inflatablechannel 18 disposed between the proximal inflatable cuff 16 and thedistal inflatable cuff 17. The inflatable frame 13 can be from about 5to about 30 cm in length, preferably about 10 to about 20 cm in length.Disposed between the proximal inflatable cuff 16, the distal inflatablecuff 17 and the elongated inflatable channel 18 is a thin flexible layer21 that forms a longitudinal lumen 22 which can confine a flow of fluidtherethrough. The thin flexible layer 21 may be made from the samematerial as the inflatable cuffs 16 and 17 and elongated channel 18 andbe integral with the construction of those elements forming a monolithicstructure. The thin flexible layer 21 and the materials used to form theframe structure 13 can have a wall thickness of about 0.1 to about 0.5mm, preferably about 0.15 to about 0.25 mm. The inflatable frame 13 maybe constructed from any suitable medical polymer or other material,including fluoropolymers, PVCs, polyurethanes, PET, ePTFE and the like.Preferably the inflatable frame 13 and thin flexible layer 21 are madefrom ePTFE. A proximal heck portion 23 is attached to the proximal endof the inflatable frame structure 13 and serves as an additional meansto seal the graft against the inside of a body passageway, provides ameans of biasing a proximal end of the graft 11, and provides a smoothflow transition into longitudinal lumen 22.

An expansion member 24 having a proximal end 25 and a distal end 26 hasthe distal end secured to the proximal end 14 of the frame 13. Thedistal end 26 of the expansion member may also be secured to theproximal neck portion 23. The expansion member 24 can be made fromexpandable rings 27 formed in a zig-zag pattern and connected by links28. The expansion member 24 is preferably a self-expanding member thatexpands to contact the inside wall of a body passage upon release from aconstrained state. The expansion member 24 may be made from any suitablematerial that permits expansion from a constrained state, preferably ashape memory alloy such as Nitinol. The expansion member 24 may beconfigured to self expand from a constrained state or be configured toexpand as a result of an outward radial force applied from within. Othermaterials suitable for construction of the expansion member 24 includestainless steel, MP35N alloy, shape memory alloys other than Nitinol,fiber composites and the like. The links 28 allow articulation of theexpansion member 24 to traverse curvature of a patient's anatomy bothduring delivery and in situ. The expansion member 24 has a generallycylindrical shape but may also have outwardly directed protuberances 32that are designed to engage the inside surface of a body passage. Theexpansion member 24 is generally cylindrical in shape when deployed,although the expansion member can conform to the shape of the vesselwithin which it is deployed, and can have a length of about 0.5 to about5 cm, preferably about 1 to about 4 cm. The diameter of the expansionmember 24 is typically similar to that of the inflatable cuffs 16 and17, and can be about 10 to about 35 mm, preferably about 16 to about 28mm. The high strength material from which the expansion member 24 ismade can have a cross sectional dimension of about 0.1 to about 1.5 mm,preferably about 0.25 to about 1 mm.

The graft 10 is generally deployed by inflation of the inflatable framestructure 13 with a pressurized material of solid particles, gas, fluidor gel which can be injected through an injection port 33. Thepressurized material may contain a contrast medium which facilitatesimaging of the device while being deployed within a patient's body. Forexample, radiopaque materials such as bismuth, barium, gold, platinum,tantalum or the like may be used in particulate or powder form tofacilitate visualization of the graft under fluoroscopy. Fixedradiopaque markers may also be attached or integrally molded into thegraft for the same purpose, and may be made from the same radiopaquematerials discussed above.

FIG. 2 shows a longitudinal cross sectional view of the endovasculargraft shown in FIG. 1. Within the proximal inflatable cuff 16 is a fluidtight chamber 41 which is in fluid communication with a fluid tightchamber 42 of the elongated inflatable channel 18. The fluid tightchamber 42 of the elongated inflatable channel is in fluid communicationwith a fluid tight chamber 43 within the optional distal inflatable cuff17. A longitudinal axis 44 of the graft 10 is shown in addition to aproximal inlet axis 45 which forms an inlet axis angle 46 with thelongitudinal axis. The angled inlet axis 45 is generally created by theproximal neck portion 23 and provides the graft with a profile which canconform to the morphology of a patient's vasculature. The expansionmember 24 has a longitudinal axis 47 which is generally coextensive withthe proximal inlet axis 45, but can further bend to conform to localanatomy including neck angulation of a diseased vessel.

FIG. 3 shows an enlarged view of the longitudinal cross sectional viewof a portion of the proximal end 11 of the graft 10 shown in FIG. 2. Amore detailed view of the fluid tight chamber 41 of the proximalinflatable cuff 16 can be seen as well as a more detailed view of theattachment of the distal end 26 of the expansion member 24 to theproximal neck portion 23. The thin flexible layer 21 can be seendisposed between the proximal inflatable cuff 16 and the elongatedinflatable channel 18. The expandable rings 27 of the expansion member24 are connected by links 28 which can be made from the same material asthe expansion member or any other suitable material such as abiocompatible fiber or a metal such as stainless steel or Nitinol.

FIG. 4 is a transverse cross-sectional view of an embodiment of anendovascular graft 51, having features of the invention. The proximalinflatable cuff 52, distal inflatable cuff 53, and elongated inflatablechannel 54 are formed by sealingly bonding strips of material 55 over atubular structure 56. The strips 55 are bonded at the edges 57 so as toform fluid tight chambers 58 therein. If the material of the strips 55which have been bonded to the tubular structure 56 are of a permeablecharacter, an additional material may be used to coat the inside of thefluid tight chambers in order to make them impermeable to fluids.Alternatively, the material of the strips 55 and the material of theelongated tubular member 56 adjacent thereto may be made impermeable byundergoing further thermal, mechanical, or chemical processing.Preferably, thermo-mechanical compaction would be used to render thefluid tight chambers 58 impermeable to fluids which would be suitablefor inflating the graft 51.

The proximal end 61 of the graft 51 has a proximal neck portion 62 whichhas an inlet axis 63 which forms an inlet axis angle 64 with alongitudinal axis 65 of the graft. The inlet axis angle 64 allows thegraft 51 to better conform to morphology of a patient's vascularchannels. An expansion member 66 is also located at the proximal end 61of the graft 51 and is formed of expandable rings 67 held together bylinks 68. The expansion member 66 has a longitudinal axis 71 which cancoincide with the inlet axis 63 of the proximal neck portion 62. Thegraft 51 has a thin flexible layer 72 which extends from the distal end73 of the graft 51, to the proximal end of the graft 61, including theproximal neck portion 62. The thin flexible layer 72 forms alongitudinal lumen or channel 74 upon deployment of the graft, whichconfines a flow of blood or other bodily fluid therethrough.

FIG. 5 is an enlarged view of the longitudinal cross-sectional view ofthe endovascular graft of FIG. 4. A more detailed view of the fluidtight chamber 58 of the proximal inflatable cuff and elongatedinflatable channel can be seen. The edges of the strips 57 which formthe proximal inflatable cuff 52 and the elongated inflatable channel 54are bonded at the edges by any suitable technique such as the use ofadhesives, solvents, or heat. Suitable adhesives would include epoxiesand cyanoacrylates or the like. Materials suitable for use as the thinflexible layer 72 or the strips 55 includes Dacron, Nylon, Teflon, andalso such materials as PVC, polyethylene, polyurethane and ePTFE.

FIGS. 6 and 7 depict an endovascular graft 81 having features of theinvention which has a first bifurcated portion 82 and a secondbifurcated portion 83. A main body portion 84 of the graft 81 has aproximal end 85 and a distal end 86 with a proximal neck portion 87disposed at the proximal end as well as an expansion member 91 which canbe formed of expandable rings 92 of a suitable material which have beenlinked together. At the distal end 86 of the main body portion 84 thereis an optional distal inflatable cuff 93 which is connected fluidly to aproximal inflatable cuff 94 by an elongated inflatable channel 95. Thedistal inflatable cuff 93 may optionally be replaced by a manifold orother suitable structure for fluid connection between the elongatedinflatable channel 95 and the first bifurcated portion 82 or the secondbifurcated portion 83.

The first bifurcated portion 82 has a proximal end 96 and a distal end97 with an optional distal inflatable cuff 98 located at the distal end.The distal end of the first bifurcated portion 97 may have an expansionmember in conjunction with or in place of the distal inflatable cuff 98.The proximal end 96 of the first bifurcated portion 82 is attached tothe distal end 86 of the main body portion 84 of the graft 81. The firstbifurcated portion 82 has an optional inflatable elongated channel 101which fluidly connects the distal inflatable cuff 98 of the firstbifurcated portion 82 with the distal inflatable cuff 93 of the mainbody portion 84. The inflatable elongated channel 101 also providessupport for first bifurcated portion 82.

The second bifurcated portion 83 generally has a structure similar tothat of the first bifurcated portion 82, with a proximal end 102 and adistal end 103. The distal end 103 has an optional distal inflatablecuff 104. The proximal end 102 of the second bifurcated portion 83 isconnected to the distal end 86 of the main body portion 84 of the graft81. The distal end of the second bifurcated portion 103 may have anexpansion member in conjunction with or in place of the distalinflatable cuff 104. The second bifurcated portion 83 has an optionalinflatable elongated channel 105 which fluidly connects the distalinflatable cuff 104 of the second bifurcated portion 83 with the distalinflatable cuff 93 of the main body portion 84. The inflatable elongatedchannel 105 also provides support for the second bifurcated portion 83.The inflatable elongated channel of the first bifurcated portion 101 andinflatable elongated channel of the second bifurcated portion 105 mayhave a linear configuration as shown, a helical configuration similar tothe main body portion 84, or any other suitable configuration. Disposedbetween the proximal inflatable cuff 94, distal inflatable cuff 93 andelongated inflatable channel 95 of the main body portion 84 of the graft81 is a thin flexible layer 106 which forms a longitudinal lumen 107 toconfine the flow of blood or other bodily fluid therethrough. Disposedbetween the distal inflatable cuff 98 and the elongated inflatablechannel 101 of the first bifurcated portion 82 and the distal inflatablecuff 93 of the main body portion 84 is a first thin flexible layer 108which forms a longitudinal lumen 109 which is in fluid communicationwith the longitudinal lumen 107 of the main body portion 84. The secondbifurcated portion may also be formed separate of a main body portionand be joined to the main body portion after percutaneous deliverythereof by docking methods. The first and second bifurcated portions 82and 83 are generally cylindrical in shape when deployed, although theycan conform to the shape of a vessel within which they are deployed, andcan have a length from about 1 to about 10 cm. The outside diameter ofthe distal ends of the first and second bifurcated portions 82 and 83can be from about 2 to about 30 mm, preferably about 5 to about 20 mm.

A second thin flexible layer 111 is disposed between the distalinflatable cuff 104 and elongated inflatable channel 105 of the secondbifurcated portion 83 and the distal inflatable cuff 93 of the main bodyportion 84. The second thin flexible layer 111 forms a longitudinallumen 112 which is in fluid communication with the longitudinal lumen107 of the main body portion 84. The thin flexible layer of the firstbifurcated portion surrounds the elongated lumen of the first bifurcatedportion. The thin flexible layer of the second bifurcated portionsurrounds the elongated lumen of the second bifurcated portion.

FIGS. 8A-8C depict an embodiment of an endovascular graft 121 havingfeatures of the invention in various stages of deployment. In FIG. 8A,an inflation catheter 122 is connected to an injection port 123 in afirst bifurcated portion 124 of the endovascular graft 121. Theinjection port 123 is connected to a distal inflatable cuff 125 of thefirst bifurcated portion 124 and is in fluid communication with a fluidtight chamber 126 therein. The first bifurcated portion 124 and a mainbody portion 127 have been substantially inflated in FIG. 8A, however, asecond bifurcated portion 128 has been prevented from deployment byrupture discs 131 which have been disposed within fluid tight chambers132 of the elongated inflatable channels 133 of the main body portion127 which are connected to fluid tight chambers 134 of elongatedinflatable channels 135 of the second bifurcated portion 128. In FIG.8B, the second bifurcated portion 128 has been substantially deployedsubsequent to a rupture or bursting of the rupture discs 131 disposedwithin the fluid tight chambers 132 and 134 of the elongated inflatablechannels 133 and 135 which permitted the flow of a pressurized substancetherein. FIG. 8C shows the endovascular graft fully deployed andillustrates detachment of a distal end 136 of the inflation catheter 122from the injection port 123 which is carried out by increasing thepressure within the inflation catheter until a disconnect mechanism 137is triggered.

FIG. 9A illustrates a longitudinal cross-sectional view taken at 9-9 ofFIG. 8A. The one-way inflation valve 141 has an outer wall 142, an innerlumen 143, an annular spring stop 144, an annular ball seal 145, asealing body 146 and a sealing spring 147. The configuration depicted inFIG. 9A allows for the ingress of an inflation medium in the directionof the arrow 148 while preventing an egress of same once pressure isremoved.

FIG. 9B illustrates an alternative one way valve. The one-way inflationvalve 149 has an outer wall 149A, an inner lumen 149B, a first reedvalve 149C, and a second reed valve 149D which is fluidly sealed withthe first reed valve in a relaxed state. The configuration depicted inFIG. 9B allows for the ingress of an inflation medium in the directionof the arrow 149E while preventing an egress of same once pressure isremoved.

FIG. 9C illustrates an alternative seal 150. The seal has an outer wall150A, an inner lumen 150B, a plug 150C and a sealing surface 150D. Theplug 150C has a sealing head 150E which sealingly engages the sealingsurface 150D by irreversible deployment by application of force to theplug in the direction of the arrow 150F.

FIG. 10 depicts a longitudinal cross-sectional view of a rupture disc151 taken at 10-10 of FIG. 8C. The rupture disc 151 has a wall member152 which is sealingly secured to the inside surface 153 of a fluidtight chamber 154. The wall member 152 is configured to fail underpressure prior to the failure of the surrounding wall 155 of the fluidtight chamber 154 under pressure. The rupture disc 151 allows fordeployment and inflation of fluid tight chambers other than those whichhave been sealed by the rupture disc. Once sufficient force or pressureis exerted against the wall 152 of the rupture disc to cause failure,the rupture disc 151 will burst and permit the ingress of an inflationmedium and deployment of a portion of an inflatable graft, previouslysealed by the rupture disc.

FIG. 11 depicts a graphical representation of inflation pressure 161versus the time 162 at an injection port of an inflatable graft asdepicted in FIGS. 8A-8C during the deployment process. P₁ represents theinflation pressure at the injection port prior to the rupturing of anyrupture discs in the endovascular graft. P₂ represents the pressurerequired to cause failure or bursting of the weakest rupture disc in theendovascular graft after which a portion of the endovascular graftpreviously sealed by the weakest rupture disc is inflated and deployed.The pressure then increases over time to P₃ which is the pressure levelrequired to cause failure or bursting of a second rupture disc. P₄ isthe pressure level required for triggering a disconnect mechanism at thedistal end of the inflation catheter.

While particular forms of the invention have been illustrated anddescribed, it will be apparent that various modifications can be madewithout departing from the spirit and scope of the invention.Accordingly, it is not intended that the invention be limited, except asby the appended claims.

1. An endovascular graft comprising: a tubular ePTFE structure; aninflatable ePTFE structure disposed over at least a portion of the ePTFEtubular structure; and an injection port in fluid communication with theinflatable ePTFE structure for inflation of the inflatable ePTFEstructure with an inflation medium.
 2. The endovascular graft of claim1, wherein the ePTFE structure is a bifurcated structure comprisingfirst and second bifurcated tubular structures.
 3. The endovasculargraft of claim 2, wherein the inflatable ePTFE structure is disposedover at least a portion of the first and second bifurcated tubularstructures.
 4. The endovascular graft of claim 1, wherein the inflatableePTFE structure is longitudinally disposed over the tubular ePTFEstructure.
 5. The endovascular graft of claim 2, wherein the inflatableePTFE structure is longitudinally disposed over at least a portion ofthe first and second bifurcated tubular structures.
 6. The endovasculargraft of claim 1, further comprising a valve configured to allow foringress of an inflation medium and to prevent egress of the inflationmedium.
 7. The endovascular graft of claim 1, wherein said tubular ePTFEstructure has a proximal end and a distal end.
 8. The endovascular graftof claim 7, further comprising at least one inflatable cuff disposed atthe proximal or distal end of said tubular ePTFE structure.
 9. Theendovascular graft of claim 8, further comprising an expansion membersecured to the proximal or distal end of said tubular structure.
 10. Theendovascular graft of claim 9, wherein the at least one inflatable cuffand the expansion member are disposed at the proximal end of the tubularstructure.
 11. The endovascular graft of claim 10, wherein the at leastone inflatable cuff disposed at the proximal end of the tubularstructure is configured to sealingly engage an interior surface of avessel wall.
 12. The endovascular graft of claim 9, wherein theexpansion member comprises linked expandable rings.
 13. The endovasculargraft of claim 12, wherein the linked expandable rings are comprisepseudoelastic shape memory alloy.
 14. The endovascular graft of claim 13wherein the linked expandable rings further comprise outward directedprotuberances.
 15. A method of deploying the endovascular graft of claim1, comprising: percutaneously delivering the endovascular graft to adesired location within a body channel of a patient with a catheterbased system; and pressurizing the inflatable channel with an inflationmedium.
 16. A method of deploying an endovascular graft comprising:providing an inflatable endovascular graft comprising a tubular ePTFEstructure; an inflatable ePTFE structure disposed over at least aportion of the ePTFE tubular structure; and an injection port in fluidcommunication with the inflatable ePTFE structure for inflation of theinflatable ePTFE structure with an inflation medium; positioning thegraft in a desired location within a body channel of a patient; andinflating the ePTFE inflatable structure of the graft to form a sealagainst the body channel.
 17. The method of claim 16, wherein theendovascular graft is positioned by percutaneous delivery to a patient'svasculature.
 18. The method of claim 16, wherein the inflatable ePTFEstructure is inflated by injecting a pressurized material through aninflation catheter and into the injection port.
 19. The method of claim18, further comprising disconnecting the inflation catheter from theinjection port by applying inflation pressure sufficient to trigger adisconnect mechanism.